CompletedPhase 1

The Anticariogenic Effect of Silver Diamine Fluoride and Sodium Fluoride Varnish

Malaysia49 participantsStarted 2023-02-01

Plain-language summary

Sodium Fluoride (NAF) varnish was considered as the treatment of Early Childhood Caries (ECC). However, the emergence of Silver Diamine Fluoride (SDF) has become more popular to tackle dental caries among children. SDF has silver ions that harbor antibacterial properties that play a crucial role in arresting active, cavitated carious lesions and has fluoride ions that are important in remineralizing enamel and dentin. This randomized control trial aims to compare the effect of SDF and NaF varnish on the salivary pH and density of Streptococcus mutans and Lactobacillus. 49 subjects below 6 years old, attending dental treatment at the Faculty of Dentistry, Universiti Teknologi MARA (UiTM) were recruited and were divided into two groups of treatment: 38% SDF or 5% SDF. Saliva samples of each subject were collected to test for salivary pH and density of S. mutans and Lactobacillus before the treatment and after 3 months of treatment. The salivary pH were tested using a calibrated pH meter. Saliva samples were subjected to microbiological analysis using Colony Forming Unit (CFU) and quantitative Polymerase Chain Reaction (qPCR) technique. The findings of this study will be used to support the use of SDF as an alternative to NaF varnish and to develop a recommendation guideline on the clinical use of SDF in ECC management.

Who can participate

Age range

4 Years – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Children under 6 years old, with ECC, having at least one active dentinal caries were included in this study. The cavitated tooth was assessed using International Caries Detection and Assessment System (ICDAS). Children that only had the tooth that fulfilled the ICDAS score 5 were included. This is characterized by a distinct cavity with visible dentine, not including more than half of the tooth. The tooth must not be mobile, associated with abscess, or have the symptoms of irreversible pulpitis. Children that had been included in this study must have not been on antibiotic treatment for at least 3 months before the start of the study and not being put on such treatment throughout the study period Exclusion Criteria: * Children with any severe medical conditions, emotional or physical disorders were excluded from the study. Children that had been using chlorhexidine mouthwashes within 2 weeks before the baseline appointment or professional topical fluoride was applied in the past 6 months were also excluded. Another exclusion criteria are children that had gingival or perioral ulceration or stomatitis, or a tooth abscess, have a history of chemical allergies to silver, fluoride, potassium, iodine, and ammonia, and uncooperative child. Besides that, parents and children that were refused any type of treatment were excluded. Children who did not complete the follow up were considered dropouts.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

comparison of salivary pH

Timeframe: 3 months

comparison of salivary counts of Streptococcus mutans

Timeframe: 3 months

comparison of salivary counts of Lactobacillus

Timeframe: 3 months

Trial details

NCT IDNCT06316323

SponsorUniversiti Teknologi Mara

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-29

View on ClinicalTrials.gov More Early Childhood Caries trials

Plain-language summary

Who can participate

Age range

4 Years – 6 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.